Durbin Slams FDA's Legal Freefall On Tobacco Regulation That Jeopardizes Public Health

FDA has halted its own decision to remove JUUL, now on track to fail to meet today’s deadline to clear the market of all unauthorized synthetic vapes

WASHINGTON – In a speech on the Senate floor today, U.S. Senate Majority Whip Dick Durbin (D-IL) slammed the Food and Drug Administration’s (FDA) incoherence and inconsistency in tobacco regulation that is endangering public health.  Last week, FDA announced a decision to “stay” its previous order to remove all JUUL Lab Inc.’s vaping products from the market after previously finding these e-cigarettes fail to meet the agency’s legal standard for authorization. He also urged the agency to remove all unauthorized synthetic nicotine e-cigarettes from the market today as required by law. Durbin and Senator Susan Collins (R-ME) sent a letter to FDA urging the agency to meet today’s deadline and requested FDA answer a number of questions outlined by the Senators regarding FDA’s enforcement actions by July 20th.

Durbin said, “Let's get to the bottom line. When tobacco companies found their cigarettes falling into disfavor, they needed a replacement product. Their marketing proposal and strategy has always been addict children. They did it with cigarettes, they found one in vaping, and e-cigarettes.”

More than 2 million children in America use e-cigarettes, including an estimated more than 750,000 who started in the 9 months since FDA missed a court order to regulate JUUL and other vaping products.   

“American kids are addicted to e-cigarettes and vaping. If you don’t believe me, ask a student in high school or middle school what's going on with vaping and be told the grim reality. Numerous federal health studies have determined that JUUL is among the most popular e-cigarettes used by kids in America… The court ordered the Food and Drug Administration to regulate these products and unfortunately for nine months the FDA refused to do it.”

“I was relieved when [FDA] finally announced it was going to ban the kid-friendly e-cigarette after determining the company could not prove they presented a public health benefit,” Durbin continued. “So imagine my surprise when after FDA Commissioner Califf called to tell me the news—the agency suddenly reversed course. Not two weeks after ordering JUUL off the market, the FDA backtracked and halted its own decision… Health experts and parents across America wonder why is FDA at a legal free fall at this moment? One day they're banning the products. A week later they're putting them back on the market.”  

Additionally, press reports revealed that FDA has not taken any enforcement action against synthetic nicotine e-cigarettes that failed to submit timely applications by May 14. Durbin and Collins previously led a bipartisan Senate effort to successfully secure a provision in the fiscal year 2022 Omnibus Appropriations Bill that clarified FDA’s ability to regulate products containing synthetic nicotine as tobacco products. This legislative fix was necessary to close legal loopholes that manufacturers of kid-friendly, flavored e-cigarettes sought to sidestep the FDA, which had the potential to erase recent progress made toward curbing the nationwide youth vaping epidemic. The most popular e-cigarette among children today, Puff Bar, uses synthetic nicotine.

Durbin concluded, “FDA has another deadline today to clear the market of unauthorized synthetic nicotine e-cigarettes. And I hope the agency doesn't repeat its history of failed enforcement. The FDA is supposed to protect all Americans and particularly our children. I'm calling on FDA to finally come to its senses. Err on the side of public safety, on the side of kids, not tobacco companies. This free fall in the legal department at the FDA is unimaginable. It's not safe for America. And it's not safe for our future.”

FDA’s delays in enforcing its requirements to regulate synthetic nicotine echo similar failures by the agency to complete its review of all other e-cigarettes as required by the U.S. District Court for the District of Maryland.  Despite a court order, FDA is now ten months late in finishing its review of these vaping products, leaving dangerous, kid-friendly e-cigarettes still available on store shelves to hook children.

Video of Durbin’s floor speech is available here.

Audio of Durbin’s floor speech is available here.

Footage of Durbin’s floor speech is available here for TV Stations.